Identity
- Trade Name
- UNIVERSAL HIGH BACK MESH EXTRA LARGE FDA UDI
- Generic Name
- General-purpose patient lifting system sling/harness FDA UDI
- Device Name
- Patient Lifting Slings EUDAMED
- Model / Reference
- CCR400MXL EUDAMEDFDA UDI
Identifiers
- Catalog Number
- CCR400MXL FDA UDI
- Primary DI / UDI-DI
- 05056387405827 EUDAMEDFDA UDI
- Basic UDI-DI
- 506040783LiftingSlings33 EUDAMED
- FDA Product Code
- INE FDA UDI
- EMDN Code
- V0805038002 NON-RIGID SUPPORTS FOR LIFTS (HARNESSES) EUDAMED
- GMDN Term
- General-purpose patient lifting system sling/harness FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Patient Lifting Slings by Silvalea Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506040783LiftingSlings33 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Silvalea Limited
- EUDAMED SRN
- GB-MF-000003832
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e95f813d-5613-40b8-b8de-bc7268556576 61 fields · synced Jun 20, 2026
- FDA UDI dacbfb67-861a-473c-b739-03e9701d7817 33 fields · synced May 22, 2026